Warner Chilcott UK has decided to withdraw its application to extend the treatment scope of its female sexual dysfunction patch Intrinsa (testosterone) in Europe, due to “commercial considerations”.
Intrinsa was approved in July 2006 for the treatment of hypoactive sexual desire disorder in women who have had their uterus (womb) and both ovaries removed, and Warner acquired the product through its £3.1 billion purchase of Procter & Gamble’s pharma unit last year.
In August, the Ardee, Ireland-headquartered group submitted an application to the European Medicines Agency to extend the drug’s license to include the treatment of low libido in menopausal women but, for as yet unspecified reasons, has decided not to proceed at this time.
A company spokesperson could not be reached in time for comment, but the EMA said it would publish Warner’s withdrawal letter shortly, which may shed some more light on the move.
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